Assessing health products for fatigue and wellness
Radicle Energy™ 24: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes
This study is testing if different health and wellness products can help adults in the U.S. feel less tired and have more energy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2752 (estimated) |
| Ages | 21 Years to 105 Years |
| Sex | All |
| Sponsor | Radicle Science Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Del Mar, California) |
| Trial ID | NCT06201689 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled study evaluates the effects of various health and wellness products on fatigue and related health outcomes in adults residing in the United States. Participants will report their health indicators electronically over a 7-week period, with assessments conducted at baseline, during the study, and at the end. The study aims to determine if these products can significantly improve energy levels and reduce fatigue. Participants will not know whether they are receiving an active product or a placebo until the conclusion of the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who desire more energy and less fatigue and can potentially achieve at least a 20% improvement in their health outcomes.
Not a fit: Patients with known cardiac dysfunction, liver or kidney disease, or those who are pregnant, trying to become pregnant, or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective health products that significantly improve energy levels and reduce fatigue for many individuals.
How similar studies have performed: While similar studies have explored health products for fatigue, this specific approach is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed * Resides in the United States * Endorses more energy/less fatigue as a primary desire * Has the opportunity for at least 20% improvement in their primary health outcome * Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study Exclusion Criteria: * Report being pregnant, trying to become pregnant, or breastfeeding * Unable to provide a valid US shipping address and mobile phone number * Reports current enrollment in another clinical trial * Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * Unable to read and understand English * Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk. * Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure * Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products * Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) * Lack of reliable daily access to the internet
Where this trial is running
Del Mar, California
- Radicle Science, Inc — Del Mar, California, United States (Recruiting)
Study contacts
- Principal investigator: Emily K. Pauli, PharmD — Radicle Science, Inc
- Study coordinator: Study Manager
- Email: studymgmt@radiclescience.com
- Phone: 760-281-3898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.